Clinical and radiographic changes at tissue level implants with either a machined or a modified transmucosal neck surface: A 3-year multicentre randomized controlled proof-of-concept study.

BACKGROUND: Surface modification may yield enhanced soft tissue adhesion to transmucosal titanium implant necks. AIM: To evaluate and compare changes in soft tissues around implants with a modified hydrophilic sandblasted and acid-etched neck (mSLA; test) to those with a machined neck (M; control). MATERIALS AND METHODS: Implants with a diameter of 4.1 mm and a neck height of 1.8 mm were randomly inserted in healed sites with pristine bone of the posterior maxilla or mandible. The modified Sulcus Bleeding Index (mSBI) (primary outcome) was assessed at baseline (BL) and 6, 12 and 36 months. Secondary outcomes included the assessment of pocket probing depth (PPD), mucosal recession (REC) and clinical attachment level (CAL). Standardized radiographs were taken at time of implant placement, at BL and after 12 and 36 months. RESULTS: Of the 43 randomized subjects, 38 (19 test and 19 controls) completed the 36-month follow-up. Implant survival rates amounted to 95.5% (test) and 100% (control) (p > .05). At 36 months, 77.6% of test implants and 78.9% of control implants were without any bleeding sites (mSBI = 0; p > .05). The 36-month success rate was 86.4% in the test and 85.7% in the control group, respectively (p > .05). At 36 months, the mean radiographic bone level change from BL was 0.33 ± 0.69 mm at test implants and 0.12 ± 0.3 mm at control implants (p > .05). CONCLUSION: Tissue level implants with a hydrophilic mSLA transmucosal neck failed to yield clinical and radiographic benefits compared with implants with a machined neck up to 3 years.

Xenogenic collagen matrix or autologous connective tissue graft as adjunct to coronally advanced flaps for coverage of multiple adjacent gingival recession: Randomized trial assessing non-inferiority in root coverage and superiority in oral health-related quality of life.

AIM: To evaluate the non-inferiority of the adjunct of a xenogeneic collagen matrix (CMX) or connective tissue graft (CTG) to coronally advanced flaps (CAF) for coverage of multiple adjacent recessions and compare superiority in patient-reported outcomes (PROM). MATERIAL AND METHODS: One hundred and eighty-seven subjects (92 CMX) with 485 recessions in 14 centres were randomized and followed up for 6 months. Patients filled daily diaries for 15 days to monitor patient-reported experience. The primary outcome was changed in position of the gingival margin. Multilevel analysis used centre, subject and tooth as levels and baseline parameters as covariates. RESULTS: Average baseline recession was 2.5 ± 1.0 mm. The surgery was 15.7 min shorter (95%CI from 11.9 to 19.6, p < .0001) and perceived lighter (11.9 VAS units, 95%CI from 4.6 to 19.1, p = .0014) in CMX subjects. Time to recovery was 1.8 days shorter in CMX. Six-month root coverage was 1.7 ± 1.1 mm for CMX and 2.1 ± 1.0 mm for CTG (difference of 0.44 mm, 95%CI from 0.25 to 0.63 mm). The upper limit of the confidence interval was over the non-inferiority margin of 0.25 mm. Odds of complete root coverage were significantly higher for CTG (OR = 4.0, 95% CI 1.8-8.8). CONCLUSION: Replacing CTG with CMX shortens time to recovery and decreases morbidity, but the tested generation of devices is probably inferior to autologous CTG in terms of root coverage. Significant variability in PROMs was observed among centres.

Immediate versus delayed implant placement after anterior single tooth extraction: the timing randomized controlled clinical trial.

AIM: To compare need for bone augmentation, surgical complications, periodontal, radiographic, aesthetic and patient reported outcomes in subjects receiving implant placement at the time of extraction (Immediate Implant) or 12 weeks thereafter. METHODS: Subjects requiring single tooth extraction in the anterior and premolar areas were recruited in seven private practices. Implant position and choice of platform were restoratively driven. Measurements were performed by calibrated and masked examiners. RESULTS: IMI was unfeasible in 7.5% of cases. One hundred and 24 subjects were randomized. One implant was lost in the IMI group. IMI required bone augmentation in 72% of cases compared with 43.9% for delayed (p = 0.01), while wound failure occurred in 26.1% and 5.3% of cases, respectively (p = 0.02). At 1 year, IMI had deeper probing depths (4.1 ± 1.2 mm versus 3.3 ± 1.1 mm, p < 0.01). A trend for greater radiographic bone loss was observed at IMI over the initial 3-year period (p-trend < 0.01). Inadequate pink aesthetic scores were obtained in 19% of delayed and in 42% of IMI implant cases (p = 0.03). No differences in patient reported outcomes were observed. CONCLUSIONS: Immediate implant placement should not be recommended when aesthetics are important, IMI should be limited to selected cases. Longer follow-up is needed to assess differences in complication rates.

Three-year outcomes of Straumann Bone Level SLActive dental implants in daily dental practice: a prospective non-interventional study.

OBJECTIVE: The aim of this investigation was to evaluate the performance of Straumann Bone Level SLActive implants in various clinical situations in daily dental practice for up to 3 years. METHOD AND MATERIALS: This was a prospective, multicenter, non-interventional study in which implants were placed within approved indications in any situation deemed suitable by the treating clinician. No implant placement or loading protocol was specified, and implants were placed according to the routine treatment protocols at each participating center. RESULTS: In this analysis, data were available from 342 implants in 233 patients in three countries (USA, Canada, and Switzerland). One or two implants were placed in the majority of patients (70.8% and 19.3%, respectively), mostly in the maxilla (71.3%); almost half (47.7%) were placed in the esthetic zone. Implant placement after 4 to > 16 weeks of healing was preferred in Switzerland (92.0%), while 42.0% of implants were placed immediately in the USA and Canada. A flapless procedure was performed in 25.2% of cases in the USA and Canada, compared to 0.5% in Switzerland. Cumulative implant survival and success rates after 3 years were 97.5% and 93.5%, respectively. CONCLUSION: Straumann Bone Level Implants can achieve favorable outcomes and high survival rates after 3 years in daily dental practice. The survival and success rates were comparable with those achieved in formal controlled clinical trials.

Success rate of paramedian palatal implants in adolescent and adult orthodontic patients: a retrospective cohort study.

The purpose of this study was to examine the success rate of paramedian palatal Orthosystem first- and second-generation implants used for anchorage in orthodontic treatment in patients treated by one experienced orthodontist. The records of 143 patients (90 female, 53 male, median age: 15.7 years, range: 10.2-50.9) receiving 145 palatal implants of the first or second generation (Orthosystem, Straumann AG, Basel, Switzerland) were examined. All the palatal implants were placed in a paramedian palatal location by three experienced surgeons. Stable implants were orthodontically loaded after a healing period of 3 months. Out of the 145 inserted paramedian palatal implants only seven implants (4.8%) were not considered stable after insertion. All the successfully osseointegrated implants remained stable during orthodontic treatment. Paramedian palatal implants are highly reliable and effective devices to obtain skeletal anchorage for orthodontic treatment. This study has shown that the paramedian location is a good alternative to the median location.

A prospective noninterventional study to document implant success and survival of the Straumann Bone Level SLActive dental implant in daily dental practice.

OBJECTIVES: Clinical studies to assess dental implants are common in implantology, but such studies are usually performed for specific indications and following a specific protocol with strict inclusion and exclusion criteria. The aim of the current study was to evaluate the Straumann Bone Level SLActive dental implant in a prospective, multicenter, noninterventional trial. METHOD AND MATERIALS: The implant could be used in whatever manner was deemed suitable by the clinician, within approved indications. No particular placement or loading protocol was specified. A total of 1,532 implants were placed in 852 patients in 123 centers in nine countries in the US and Europe. After exclusion of three countries due to patient enrollment and data issues, 759 patients with 1,355 implants were analyzed. RESULTS: Most patients received one or two implants (58.6% and 25.3% of patients, respectively), and 90% of cases were performed with a raised flap. A submerged healing protocol was significantly more prevalent in European centers, while transmucosal healing was significantly more prevalent in North American centers. After 1 year, 538 patients with 908 implants were available for evaluation. The cumulative implant survival and success rates were 98.5% and 96.0%, respectively. CONCLUSIONS: This prospective noninterventional study evaluated the use of Straumann Bone Level SLActive dental implants in a large number of patients. The cumulative survival and success rates were similar to those observed in controlled clinical trials, confirming this dental implant's clinical applicability in daily practice.

Effects of a single topical doxycycline administration adjunctive to mechanical debridement in patients with persistent/recurrent periodontitis but acceptable oral hygiene during supportive periodontal therapy.

OBJECTIVES: To evaluate the efficacy of a slow release doxycycline gel (SRD) adjunctively administered to non-surgical therapy in subjects with recurrent or persistent periodontitis but acceptable oral hygiene during supportive periodontal care. MATERIAL & METHODS: In this single blind, parallel group, multicentre study, 202 of 203 recruited periodontal maintenance subjects with recurrent or persistent periodontitis were randomly assigned to subgingival ultrasonic/sonic instrumentation (USI) with (test) or without (control) subsequent administration of SRD in all residual periodontal pockets ≥4 mm. Intergroup differences in probing depth, BOP reductions, treatment time, probing attachment levels were evaluated at 3, 6 and 12 months. The primary outcome was the inter-group difference in absolute change of probing pocket depth (PPD) 3, 6 and 12 months after intervention. RESULTS: At baseline, the two groups were comparable. At 3 months, the test group showed a significantly higher decrease in mean probing depth than the control group at 3 months (mean difference = 0.11 mm, 95% CI 0.03-0.19 mm, p = 0.003). Administration of SRD resulted in significantly greater odds of transition of bleeding pockets ≥5 mm to a category of non bleeding sites with PPD ≤4 mm at 3 and 6 months (O.R. = 1.4, 95% CI 1.2-1.8 at 3 months). At 6 months, SRD benefit was observed only in the deeper pockets. 7.5% of subjects (no significant difference between test and control) showed disease progression (attachment loss ≥2 mm) and were exited from the study. No difference in the incidence of adverse events was observed between groups. CONCLUSION: The trial results show that topically administered SRD may provide short-term benefit in controlling inflammation and deep pockets in treated periodontal patients participating in a secondary prevention programme and able to maintain a satisfactory level of oral hygiene.

Clinical outcomes following treatment of human intrabony defects with GTR/bone replacement material or access flap alone. A multicenter randomized controlled clinical trial.

AIM: This prospective multicenter randomized controlled clinical trial was designed to compare the clinical outcomes of papilla preservation flap surgery with or without the application of a guided tissue regeneration (GTR)/bone replacement material. MATERIALS AND METHODS: One hundred and twenty-four patients with advanced chronic periodontitis were recruited in 10 centers in seven countries. All patients had at least one intrabony defect of > or = 3 mm. The surgical procedures included access for root instrumentation using either the simplified or the modified papilla preservation flap in order to obtain optimal tissue adaptation and primary closure. After debridement, the regenerative material was applied in the test subjects, and omitted in the controls. At baseline and 1 year following the interventions, clinical attachment levels (CALs), probing pocket depths (PPDs), recession, full-mouth plaque scores and full-mouth bleeding scores (FMBS) were assessed. RESULTS: One year after treatment, the test defects gained 3.3 +/- 1.7 mm of CAL, while the control defects yielded a significantly lower CAL gain of 2.5 +/- 1.5 mm. Pocket reduction was also significantly higher in the test group (3.7 +/- 1.8 mm) when compared with the controls (3.2 +/- 1.5 mm). A multivariate analysis indicated that the treatment, the clinical centers, baseline PPD and baseline FMBS significantly influenced CAL gains. Odds ratios (ORs) of achieving above-median CAL gains were significantly improved by the test procedure (OR = 2.6, 95% CI 1.2-5.4) and by starting with deeper PPD (OR = 1.7, 1.3-2.2) but were decreased by receiving treatment at the worst-performing clinical center (OR = 0.9, 0.76-0.99). CONCLUSIONS: The results of this trial indicated that regenerative periodontal surgery with a GTR/bone replacement material offers an additional benefit in terms of CAL gains, PPD reductions and predictability of outcomes with respect to papilla preservation flaps alone.

Effect of bioresorbable fibres (Polyfibre) and a bioresorbable foam (Polyfoam) on new bone formation. A short term experimental study on the rabbit skull.

The aim of the study was to evaluate two bioresorbable polylactic acid (PLA) filler materials in a guided bone regeneration (GBR) model system. The first was Polyfibre, a fibrous PLA filler material. Polyfoam, the second material tested, consisted of a spongy PLA filler material. In each group there were eight rabbits. In test rabbits a flap was raised uncovering the calvaria. A hemispherical PLA dome was filled with Polyfibre or Polyfoam material and periphereal blood and anchored onto the calvaria. Eight rabbits with the same domes, filled with blood alone, served as controls. The rabbits were sacrificed at 1 or 2 months. Histomorphometric measurements of regenerated total tissue volume, bone height and bone volume were carried out in undecalcified sections under a light microscope. At 1 month the totally filled volume attained 87% (range 82-91) in the fibre group, including 25% (23-27) fibres, 87% (85-95) in the foam group, including 15% (15-16) foam, and 55% (16-100) in the controls. The volume of mineralized bone was 12% (7-15) in the fibre group, 15% (12-18) in the foam group and 6% (1-11) in control domes. Bone height attained 48% (27-79) in the fibre group, 37% (31-58) in the foam group and 45% (14-67) in the control group. At 2 months, tissue volume attained 86% (85-87) including 26% (22-29) fibres, bone volume attained 13% (7-21) and bone height attained 56% (42-78) in the Polyfibre group. In the Polyfoam group, they were 83% (55-99) including 18% (15-19) foam, 13% (7-24) and 49% (29-74). In control domes, tissue volume was 82% (35-100), bone volume 20% (9-27) and bone height 86% (60-100). The Polyfibre and Polyfoam material was excellently integrated. No adverse reactions were found in the surrounding tissues. Direct bone apposition was observed onto the material. In conclusion, Polyfibre and Polyfoam material had a positive effect on initial bone and tissue formation but was a hindrance to increasing tissue volume, bone volume or bone height at 2 months compared to control specimens. The Polyfibre and Polyfoam material provoked no adverse reactions in the surrounding tissues and allowed for extensive angiogenesis.

Enamel matrix proteins in the regenerative therapy of deep intrabony defects.

AIM: This prospective multicentre randomized controlled clinical trial was designed to compare the clinical outcomes of papilla preservation flap surgery with or without the application of enamel matrix proteins (EMD). MATERIAL AND METHODS: 172 patients with advanced chronic periodontitis were recruited in 12 centers in 7 countries. All patients had at least one intrabony defect of > or =3mm. Heavy smokers (> or =20 cigarettes/day) were excluded. The surgical procedures included access for root instrumentation using either the simplified or the modified papilla preservation flap in order to obtain optimal tissue adaptation and primary closure. After debridement, roots were conditioned for 2 min with a gel containing 24% EDTA. EMD was applied in the test subjects, and omitted in the controls. Postsurgically, a strict plaque control protocol was followed. At baseline and 1 year following the interventions, clinical attachment levels (CAL), pocket probing depths (PPD), recession (REC), full-mouth plaque scores and full-mouth bleeding scores were assessed. A total of 166 patients were available for the 1-year follow-up. RESULTS: At baseline, 86 test and 86 control patients presented with similar subject and defect characteristics. On average, the test defects gained 3.1+/-1.5 mm of CAL, while the control defects yielded a significantly lower CAL gain of 2.5+/-1.5 mm. Pocket reduction was also significantly higher in the test group (3.9+/-1.7 mm) when compared to the controls (3.3+/-1.7 mm). A multivariate analysis indicated that the treatment, the clinical centers, cigarette smoking, baseline PPD, and defect corticalisation significantly influenced CAL gains. A frequency distribution analysis of the studied outcomes indicated that EMD increased the predictability of clinically significant results (CAL gains > or =4 mm) and decreased the probability of obtaining negligible or no gains in CAL (CAL gains <2 mm). CONCLUSIONS: The results of this trial indicated that regenerative periodontal surgery with EMD offers an additional benefit in terms of CAL gains, PPD reductions and predictability of outcomes with respect to papilla preservation flaps alone.